MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Protective Measures Problem (3015)

Patient Problem Muscular Rigidity (1968)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 28-oct-2022, udi#: (b)(4), implanted: (b)(6) 2021, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient (b)(6) 2022, it was reported that the patient was experiencing a reduced effect of the pump and spasticity.The patient underwent an x-ray and it was noted that the hcp could not see the first part of the catheter, though the rest of the catheter was visible.The sideport or catheter access port (cap) was accessed with puncture going very smoothly, but the hcp was unable to withdraw any fluid other than "half a drop of clear moisture".It was noted that the spasticity was not too disruptive and the patient's condition was "not too good" so the hcp was going to refrain from performing a revision.Additional information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) on 2022-apr-12.It was reported that the cause of the inability to aspirate the catheter and the issue of the catheter not being radiopaque was not determined.It was confirmed that the health condition causing the hcp to delay the revision procedure was unrelated to the device or therapy.The issue was not considered resolved.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14092112
• MDR Text Key: 289209219
• Report Number: 3004209178-2022-04640
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Date Device Manufactured: 10/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1